Kornimate/medical-research-clean huggingface dataset:
decitabine plus mbu/cy for high risk acute leukemia with mrd pre-hsct

Conditions: Stem Cell Transplant Complications; Leukemia, Myeloid, Acute; Leukemia Relapse

Summary: allogeneic haematopoietic stem cell transplantation (allo-hsct) remains one of the currently available curative therapies for acute leukemia (al). leukemia relapse is one of the mainly causes of transplant failure. we reported previously that patients with high-risk molecular biomarkers who still have detectable minimal residual disease(mrd) pre-hsct were at very high risk of relapse, with cumulative relapse rate of 50-80%. decitabine has been demonstrated efficacy in the treatment of patients with recurrent or refractory leukemia and myelodysplastiv syndrome. it was reported that the combination of decitabine, with busufan and cyclophosphamide as a preparative regimen for allo-hsct using hla-matching donors was safe and effective. in this prospective, single-arm clinical trial, we aimed to examine the efficacy of combining decitabine with modified busulfan and cyclophosphamide (mbu/cy) as a preparative regimen for allo-hsct in patients with very high-risk al and detectable mrd pre-hsct.

patients enrolled in this study would receive decitabine 200mg·m-2·d-1 on day -12 and -11 pre-hsct. the conditioning therapy for human leukocyte antigen (hla)-mismatched hsct patients was modified bu/cy plus atg (thymoglobulin; sang stat, france) consisting of cytarabine (ara-c 4 g·m-2·d-1) intravenously on days -10 to -9, busulfan (bu 3.2 mg·kg-1·d-1) intravenously on days -8 to -6, cyclophosphamide (cy 1.8 g·m-2·d-1), intravenously on days -5 to -4, semustine (me-ccnu, 250 mg·m-2), orally once on day -3, and atg (2.5 mg·kg-1·d-1) intravenously on days -5 to -2. in matched sibling transplantations, patients received hydroxycarbamide (80 mg·kg-1) orally on day -10 and a lower dose of ara-c (2 g·m-2·d-1) on day -9, but otherwise an identical regimen to the hla-mismatched patients without atg. bm samples from patients were obtained to assess leukemia status after hsct. the time points that we monitored bm samples included at time of allo-hsct; 1 month, 2 months, 3 months, 4.5 months, 6 months, 9 months, and 12 months after allo-hsct; and every 6 months thereafter to the defined endpoints or for at least until 5 years after transplantation.

Eligibility criteria:
inclusion criteria: * acute leukemia patients with mll-r,tls-erg,or sil-tal1,whose minimal residual disease were detectable pre-hsct exclusion criteria: * pregnancy women * uncontrolled severe infection

Keywords: high risk acute myeloid leukemia hematopoietic stem cell transplantation leukemia relapse preparation regimen decitabine
the effects of orally ingesting branched chained amino acids on delayed onset muscle soreness in diabetic patients

Conditions: Type 2 Diabetes; Healthy Individuals

Summary: the purpose of this study is to determine the effectiveness of the 3 branched chained amino acids (isoleucine, leucine, and valine) on treating delayed onset muscle soreness, a type of muscle pain which usually develops after exercising.

delayed onset muscle soreness is a common painful sensation experienced by individuals who have been recently inactive and begin with an unaccustomed exercise protocol. branched chained amino acids have been found as a useful supplement for promoting muscle recovery following exercise; however the effects of this supplement have not been investigated amongst individuals with diabetes.

Eligibility criteria:
inclusion criteria: * the subjects with diabetes must have been diagnosed with diabetes at least one year before the onset of the study * at least 6 weeks of physical inactivity in the upper body * bmi less than 40 exclusion criteria: * for the diabetics, hemoglobin a1c levels over 13 * pregnant * have cardiovascular diseases * have hepatic diseases * are diagnosed with rhabdomyolysis * recent upper limb injuries * upper limb neuropathy * blood pressure levels over 140/90, or lower than 90/60 * are on high doses of alpha or beta agonist/antagonists, and take any types of nsaid's, cox 2 inhibitors, calcium channel blockers, pre-gabalin's, or pain reducers

Keywords: branched chained amino acids delayed onset muscle soreness diabetes muscle damage
examining the impacts of fidget technology on attention in children with adhd

Conditions: ADHD

Summary: purpose: the purpose of this study is to investigate the usage of fidget technology and its effects on attention, working memory, and comprehension in children ages 6-13 with attention deficit hyperactivity disorder (adhd). this study aims to examine the implications of fidget usage 2 different measures of attention; attentional control (working memory domain) and comprehension (recall, encoding, and recognition). participants: 6-13 year-old clients at 3-c family services, a private mental health clinic in cary, nc, with a diagnosis of adhd (inattentive, hyperactive, or combined types). exclusion criteria: participants with an intelligence quotient (iq) below 70 as estimated by referring 3-c clinical staff, or any history of psychosis. procedures (methods): this research will use a demographic and background collecting survey to gather relevant data about each participant. parents will be asked to fill out a baseline adhd rating scale-iv: home version (adhd-rs), to account for their child's symptoms of adhd over the past 6 months. participants will be randomly assigned to one of 2 conditions, an experimental group where participants select a fidget, and a control group where participants are not provided a fidget. fidget options will include a fidget spinner, pop-it, stress ball, and fidget cube as not all children would benefit from the same type of fidget equally. participants in the experimental group will then be allowed to practice with and familiarize themselves with the fidget for 1 minute to decrease the attentional drain that the fidget may pose in its initial state. after random assignment to either control or experimental group, participants in each group will then complete the same 2-back version of the n-back attention control task (cognitivefun.net), and a video comprehension multiple choice test. after 3 minutes n-back scores will be recorded including visual correct ratio and visual response time scores. the video comprehension item is adapted from lee and list, 2019. the video is a ted talk titled "the survival of the sea turtle" ( https://www.youtube.com/watch?v=t-kmq6pgxg4). items in the multiple choice test will be aggregated to a score of percent correctness for each participant. participants may request to have questions read to them by the research assistant present.


Eligibility criteria:
inclusion criteria: * diagnosis of adhd exclusion criteria: * psychosis * iq under 70

Keywords: fidget technology adhd children developmental psychology
effect of ras/mapk pathway hyperactivation on growth' and bone' profile of the rasopathies

Conditions: RASopathy; Costello Syndrome; Noonan Syndrome; Cardio-Facio-Cutaneous Syndrome

Summary: costello syndrome (cs) and cardio-facio cutaneous syndrome (cfcs) belongs to rasopathies, a group of multisystemic disorders caused by unregulated signalling through the ras/mapk pathway, an intracellular signalling pathway regulating multiple processes such as cellular proliferation, differentiation, survival, apoptosis and also contributing to oncogenesis. they share a recognizable facial appearance, aged appearance, growth delay, muscle-skeletal anomalies, heart defects, neuropsychological features, skin and ocular abnormalities, and cancer predisposition. even though life expectancy of individuals with cs and cfcs has increased in the last years due to the improvement of patients' care and a more effective prevention of comorbidities, some of the most challenging aspects impacting on everyday living such as growth failure, accelerate senescence and skeletal-muscle defects, still need to be fully understood. this statement underlies the need to improve clinical research protocols with more innovative techniques (multi-omics profiling) in order to better understand the effect of ras/mapk pathway hyperactivations on different systems and to define possible personalized treatments.

multiomics profiling of the rasopathies

Eligibility criteria:
inclusion criteria: * clinical and molecularly confirmed diagnosis of a rasopathy exclusion criteria: * only clinical diagnosis of a rasoapthy
investigating mindfulness and music to ease radiation side effects in prostate cancer

Conditions: Prostate Cancer

Summary: in this study, the researchers will examine the implementation feasibility, acceptability, and initial effects of a brief ehealth mindfulness intervention, compared to brief relaxing music, to reduce self-reported symptoms of fatigue, anxiety, depression and sleep disturbance in a sample of localized prostate cancer patients during the receipt of radiation therapy.

eligible patients will be recruited from northwestern medicine's department of radiation oncology and northwestern memorial hospital. participants will complete an online questionnaire prior to beginning the intervention. following implementation pre-testing, the intervention will begin on week 2 of radiation therapy and last 4 weeks. upon arrival for their treatment visit, they will receive the audio program from the clinic staff. they will start the program prior to their treatment. participants will be asked to listen to the audio-program during their radiation treatment visits, using a bluetooth-enabled mp3 player with speaker instead of headphones or earbuds because they are not permitted during radiation therapy. the patient's ears need to be free to hear a possible communication from the radiation therapists if need be. audio program recordings will run 3-12 minutes. participants will turn off the program after their audio session has ended and return the audio program to the clinic staff after their treatment visit. participants will complete an online question immediately after completing the intervention, and again 1 and 3 months later.

Eligibility criteria:
inclusion criteria: * diagnosed with clinically localized prostate cancer * will receive at least 7 weeks of daily radiation therapy * at least 18 years of age * able to speak and understand english * cognitively intact and free of serious psychiatric illness (as determined by referring physician) exclusion criteria: - regular user of mindfulness meditation, which is defined as ≥ 3 times a week for the past 4 weeks

Keywords: prostate cancer mindfulness music
study of bmn 349 single dose in pizz and pimz/mash adult participants

Conditions: Alpha 1-Antitrypsin Deficiency

Summary: the goal of this clinical trial is to assess the safety and tolerability of a single oral dose of bmn 349 in participants with pizz or pimz/mash. primary outcome measures include incidence of any adverse events (including serious adverse events, dose limit toxicities, and adverse events of special interest), incidence of any laboratory test abnormalities, incidence of lung function test abnormalities and 12-lead ecg parameters. participants will receive a single dose of either bmn 349 or placebo and then monitored for safety and tolerability.


Eligibility criteria:
inclusion criteria: * participants must have confirmation of pizz or pimz genotype * females and males, of any race, 18 to 70 years of age * nonsmokers, defined as not using tobacco or nicotine-containing products for at least 6 months prior to screening exclusion criteria: * international normalized ratio (inr) \> 1.2 * alanine aminotransferase (alt) and aspartate aminotransferase (ast) levels \> 125 u/l * current or recent use of aat augmentation therapy * participants with recent (last 3 months) diagnosis of pneumonia

Keywords: 349 349-102 aatd mash pizz pimz
camrelizumab combined with apatinib mesylate for head and neck squamous cell carcinoma

Conditions: Head and Neck Squamous Cell Carcinoma

Summary: this is a prospective, open-labelled study to evaluate the efficacy and safety of camrelizumab combined with apatinib mesylate in the induction treatment of patients with locally advanced head and neck squamous cell carcinoma who were judged surgically unresectable or appropriate for non-surgical definitive therapy. the objective response rate (orr) and safety will be evaluated as the primary endpoints, the 2-year overall survival (os) rate and progression free survival (pfs) rate will be the second endpoints.


Eligibility criteria:
inclusion criteria: 1. histologically or cytologically confirmed squamous cell or poorly differentiated or undifferentiated cancer of the head and neck (the primary sites include oral cavity, oropharynx, hypopharynx, larynx, nasal cavity and sinuses); 2. clinical stage of iii-ivb (ajcc 2018); 3. surgically unresectable and/or refuse surgery or appropriate for non-surgical definitive therapy; 4. measurable disease; 5. eastern cooperative oncology group performance status (ecog ps) score: 0-1; 6. blood routine: white blood cells\> 3,000/mm3, hemoglobin\> 8g/l, platelets\> 80,000/mm3；liver function: alanine transaminase/aspartate transaminase \<2.5 times the upper limit of normal, bilirubin \<1.5 times the upper limit of normal; renal function: serum creatinine \<1.5 times the upper limit of normal; 7. sign the informed consent. exclusion criteria: 1. patients with poor-controlled arterial hypertension (systolic pressure ≥ 140 mmhg and/or diastolic pressure ≥ 90 mm hg) despite standard medical management; 2. suffered from grade ii or above myocardial ischemia or myocardial infarction, uncontrolled arrhythmias (including qt interval male ≥ 450 ms, female ≥ 470 ms). grade iii-iv cardiac insufficiency according to new york heart association (nyha) criteria or echocardiography check: left ventricular ejection fraction (lvef)\<50%; 3. has had another active malignancy within the past five years except for cervical cancer in site, in situ carcinoma of the bladder or non-melanoma carcinoma of the skin; 4. clinically significant and uncontrolled major medical conditions including but not limited to: active uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris or cardiac arrhythmia, psychiatric illness/ social situation that would limit compliance with study requirements; any medical condition, which in the opinion of the study investigator places the subject at an unacceptably high risk for toxicities; 5. patients undergoing therapy with other investigational agents; 6. women who are pregnant or breastfeeding; 7. patients with any other concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for participation in the study.
phase i study of cetuximab in combination with 5-fluoruracil, mitomycin c and radiotherapy in patients with anal cancer stage t2 (>4 cm) - t4 n0-3 m0 or any t n2-3 m0

Conditions: Locally Advanced Cancer in the Anal Region

Summary: * to establish maximum tolerated dose of the two cytotoxic drugs 5-fluoruracil and mitomycin c when given together with the antibody cetuximab in patients with locally advanced cancer in the anal region * to evaluate acute toxicity * to evaluate late toxicity * to evaluate response rate * to evaluate recurrence free survival * to evaluate overall survival


Eligibility criteria:
inclusion criteria: * age over 18 years * histologically or cytologically confirmed squamous cell cancer of the anal region (anal canal or anal margin or distal rectum) * stage t2 (≥4 cm) - t4 n0-3 m0 or any t n2-3 m0 * ecog performance status 0-1 * hb \> 100 g/l * anc \> 1.5 x 10 9/l * platelets ≥ 100 x 10 9/l * creatinine \< 1.5 x uln * bilirubin \< 1.5 x uln * alat \< 3.0 x uln * competent to comprehend, sign and date an approved informed consent form exclusion criteria: * previous pelvic irradiation * previous chemotherapy for anal cancer * previous malignancy within the last 5 years, except curatively treated non-melanoma skin cancer or carcinoma in situ of the cervix uteri * pregnant or nursing females or patients of child-bearing potential not using adequate methods of birth control * patients with active infections or any other serious underlying medical condition, which would impair the ability of the patients to receive the protocol treatment * known hypersensitivity to any of the components of the treatment * clinically significant cardiovascular disease, e.g. cardiac failure (\<12 months before treatment start), unstable angina, congestive heart failure, arrythmia requiring medication, or uncontrolled hypertension * known positive test for hepatitis c virus, chronic active hepatitis b infection * known hiv infection * any other condition or therapy which in the investigator´s opinion may pose a risk to the patient or interfere with the study objectives * any investigational agent within 30 days before enrolment * surgery (excluding diagnostic biopsy or central venous catheter placement) and/or radiotherapy within 28 days prior to inclusion in the study

Keywords: anal cancer locally advanced anal cancer cetuximab 5-fluoruracil mitomycin c radiotherapy
validation of an rlip76 assay in humans

Conditions: Type 2 Diabetes

Summary: the current proposal extends work done in mouse models evaluating the consistency of measuring rlip76 in a clinical cohort (aim 1) by using guidelines provided by the nih for validating biomarkers. we will also proceed to estimate the effect size of a potential correlation of rlip76 with standard msy treatment measures such as hgba1c, ldl, and triglyceride levels in a longitudinal prospective study ( aim 2) that will follow a cohort of patients with msy who seek care at the city of hope endocrine clinic over a 12 month period..


Eligibility criteria:
inclusion criteria: * registered patient of city of hope and followed in the endocrine clinic. must have documentation of a diagnosis of diabetes identified by the problem list in the patient's electronic health record. * must demonstrate features of msy by possessing any of the following characteristics and/or receiving treatment for diabetes, hyperlipidemia, and/or hypertriglyceridemia. * central obesity: waist circumference ≥ 102 cm or 40 inches (male), ≥ 88 cm or 36 inches (female) * dyslipidemia: tg ≥ 1.7 mmol/l (150 mg/dl) * dyslipidemia: hdl-c \< 40 mg/dl (male), \< 50 mg/dl (female) * blood pressure ≥ 130/85 mmhg * fasting plasma glucose ≥ 6.1 mmol/l (110 mg/dl)

Keywords: type 2 diabetes metabolic syndrome oxidative stress gsh
in-person lifestyle program for black adolescent girls at risk for type 2 diabetes

Conditions: Behavior, Adolescent; Childhood Obesity; Diabetes Mellitus, Type 2; Pediatric Obesity; Glucose Metabolism Disorders; Metabolic Disease; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Diabetes Mellitus

Summary: the aim of this study is to look at changes in diabetes-related risk factors in black adolescent girls who are at risk for type 2 diabetes and their primary female caregiver after both participating in a 12-week in-person lifestyle program.

enrolled adolescent/caregiver dyads will participate in the 12-week program. each week, participants will engage in 2 activities: an in-person wellness session and an at-home cooking experience using ingredients provided at the wellness session. the study will examine the pre-post difference in overall diet quality, dermal carotenoid levels, physical activity, body composition, and glycemic measures among at-risk black adolescent girls and their caregivers. investigators hypothesize that after the program, participants' diets will be higher in quality than before.

Eligibility criteria:
inclusion criteria for adolescent participants: * 12-18 years of age * self-identify as black or african american * have obesity (\>=95th percentile bmi) exclusion criteria for adolescent participants: * pregnant or within 3 months postpartum. * participated in a formal weight management program within 6 months prior to study. * currently taking medications or diagnosed with a condition known to influence metabolism, physical activity ability, or cognitive function. * have previously undergone bariatric surgery. * have type 2 diabetes. * unable to speak english or have developmental conditions that interfere with ability to communicate. inclusion criteria for caregiver participants: * 18 years or older. * proficiency in speaking english. * live in the same household as the adolescent who will also be enrolled. * prepares the majority (\>50%) of meals in the household. exclusion criteria for caregiver participants: * pregnant or within 3 months postpartum. * unable to speak english or have developmental conditions that interfere with ability to communicate.

Keywords: adolescents in-person lifestyle program diabetes prevention black girls obesity
impact on quality of life in patients undergoing total gastrectomy or proximal gastrectomy for adenocarcinoma of esophagogastric junction

Conditions: Adenocarcinoma of Esophagogastric Junction.

Summary: the purpose of this study is to find out more about differences of the quality of life in patients undergoing total gastrectomy or proximal gastrectomy for adenocarcinoma of esophagogastric junction. to find a better reconstruction for patients who received total gastrectomy.

overall, the incidence of stomach cancer worldwide is declining with geographical variation. however, an increase in the incidence rate of adenocarcinoma of esophagogastric junction, called cardia or aeg has been observed in recent years. aeg may represent a specific histopathological and biologic entity. in the treatment aeg there is argument over whether proximal gastractomy(pg) or total gastractomy (tg) should be done. the quality of life (qol) of the patients following tg or pg arouses people's attention. the purpose of this study was to evaluate differences of the quality of life in patients undergoing total gastrectomy or proximal gastrectomy for adenocarcinoma of esophagogastric junction.

Eligibility criteria:
inclusion criteria: * • pathologically confirmed gastric malignant tumor at fuscc (biopsy may be performed at other institutions but slides must be confirmed at fuscc, as is routine care at our institution), and the patients be assessed can achieve r0 radical dissection through total gastrectomy or proximal gastrectomy by three specialists. * patients 20-75 years old * normal organ function, able to tolerate surgery, no clear contraindication for surgery * no evidence of metastases of adjacent organs * be able to provide follow-up over 2 years * no specific treatment for gastric cancer before surgery * in line with the declaration of helsinki and the requirements of the hospital ethics committee. * the subjects were able to understand and comply with the trial protocol, and signed informed consent. exclusion criteria: * • aeg siewertⅰtype patients * synchronous or metachronous (less than five years) and patients with other malignancies. * cirrhosis and portal hypertension * associated with blood diseases * serious heart/ lung and kidney dysfunction or with metabolic diseases such as diabetes, hyperthyroidism. * suffering from a serious neurological disease or psychological diseases affecting the life.

Keywords: adenocarcinoma of esophagogastric junction total gastrectomy proximal gastrectomy
sym004 in metastatic colorectal cancer and ecd-egfr patients

Conditions: Metastatic Colorectal Cancer

Summary: this is a single arm, phase 2, open-label, multicenter trial in patients with metastatic colorectal cancer (mcrc) and acquired resistance to anti-epidermal growth factor receptor (egfr) monoclonal antibodies (mabs) and documented mutation of extra cellular domain egfr (ecd-egfr).


Eligibility criteria:
inclusion and exclusion criteria have been removed due to symphogen's business decision to no longer perform the clinical study.

Keywords: resistance to anti-egfr monoclonal antibodies mutation of ecd-egfr